The agreement between Biomira and the FDA concerns the design of the phase III trial and outlines definitive clinical objectives and data analyses considered necessary to support regulatory approval of Stimuvax. The trial will be conducted by Merck KGaA under terms of a licensing arrangement with Biomira.
The planned phase III trial will evaluate Stimuvax in patients with unresectable stage III non-small cell lung cancer. The primary endpoint of the trial is overall survival in patients receiving Stimuvax compared to those receiving placebo.
“This trial builds upon the encouraging results seen in Biomira’s phase IIb trial of Stimuvax in patients with stage IIIB and IV non-small cell lung cancer,” said Robert Kirkman, president and CEO of Biomira.
“In that trial, the median survival in the subset of patients with locoregional Stage IIIB disease was 30.6 months for patients receiving Stimuvax, compared with 13.3 months for patients in the control arm. The phase III trial will seek to extend and confirm these results in patients with both stage IIIA and IIIB locoregional disease.”
Biomira said that it would initiate the phase III trial by the end of the year.